NDC 70165-003

Adzenys ER

Amphetamine

Adzenys ER is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics, Lp. The primary component is Amphetamine.

• Product ID: 70165-003_4df2eebc-45bf-49a3-ae42-56b4c77905e5
• NDC: 70165-003
• Product Type: Human Prescription Drug
• Proprietary Name: Adzenys ER
• Generic Name: Amphetamine
• Dosage Form: Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-16
• Marketing Category: NDA / NDA
• Application Number: NDA204325
• Labeler Name: Neos Therapeutics, LP
• Substance Name: AMPHETAMINE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70165-003-15

450 mL in 1 BOTTLE, GLASS (70165-003-15)

• Marketing Start Date: 2017-09-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70165-003-15 [70165000315]

Adzenys ER SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204325
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-09-16

Drug Details

Active Ingredients

Ingredient	Strength
AMPHETAMINE	1.25 mg/mL

OpenFDA Data

• SPL SET ID: eb1cc8d0-4231-41ea-8535-4fd872129713
• Manufacturer:
  • Neos Therapeutics, LP
• UNII:
  • CK833KGX7E
• RxNorm Concept Unique ID - RxCUI:
  • 1945840
  • 1945844

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

Medicade Reported Pricing

70165003030 ADZENYS XR-ODT 18.8 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Adzenys ER" or generic name "Amphetamine"

NDC	Brand Name	Generic Name
70165-003	Adzenys ER	Amphetamine
70165-005	Adzenys XR-ODT	Amphetamine
70165-010	Adzenys XR-ODT	Amphetamine
66993-360	Amphetamine Extended-Release Oral Suspension	Amphetamine
50742-652	Amphetamine Sulfate	Amphetamine
69238-1563	Amphetamine Sulfate	Amphetamine
69238-1564	Amphetamine Sulfate	Amphetamine
69452-227	Amphetamine Sulfate	Amphetamine
69452-228	Amphetamine Sulfate	Amphetamine
24478-102	Dyanavel XR	amphetamine
24478-106	DYANAVEL XR	amphetamine
24478-108	DYANAVEL XR	amphetamine
24478-109	DYANAVEL XR	amphetamine
24478-110	DYANAVEL XR	amphetamine
27808-102	Dyanavel XR	amphetamine
27808-106	DYANAVEL XR	amphetamine
27808-108	DYANAVEL XR	amphetamine
27808-109	DYANAVEL XR	amphetamine
27808-110	DYANAVEL XR	amphetamine